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Vera’s IgAN Approval Kicks Off Competition with Otsuka

on July 08, 2026

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Vera Therapeutics received accelerated FDA approval for TRUTAKNA (atacicept-vymj), a BAFF/APRIL inhibitor to reduce proteinuria in adults with primary IgA nephropathy (IgAN) at risk of disease progression, on July 7, 2026.

TRUTAKNA’s approval triggers a competitive dynamic with Otsuka’s Voyxact (sibeprenlimab), an APRIL-targeting IgAN therapy already on the market, and positions Vera as the first dual BAFF and APRIL inhibitor in the IgAN treatment landscape.

The approval is based on reduction in proteinuria; continued approval depends on results from the ongoing ORIGIN 3 trial scheduled for eGFR analysis in Q3 2026, which could support a full approval filing in Q4 2026 and potential full approval in 2027.

Sources:

Vera Therapeutics Announces Alignment with U.S. FDA on Earlier ...

Vera Therapeutics Receives FDA Accelerated Approval for

Vera Therapeutics (VERA) FDA Approvals, PDUFA Dates & Drug ...

US FDA approves Vera's kidney disease drug - Reuters

Vera Therapeutics Announces Alignment with US FDA on Earlier ...

Vera Therapeutics Says FDA Grants Breakthrough Therapy Designation For Atacicept To Treat IgAN

Vera Therapeutics Announces U.S. FDA Granted Priority Review to Biologics License Application for Atacicept for Treatment of Adults with IgA Nephropathy

Vera moves into growing kidney disease space with FDA's ...

IgA Nephropathy Foundation - Facebook

VERA: Atacicept achieved strong efficacy and safety in IgAN, with US approval targeted for 2026

Vera Therapeutics vs. Otsuka: A Race Against Time in IgAN Therapy

Goldman Sachs raises Vera Therapeutics stock price target to $95 on IgAN pricing

Otsuka joins IgAN market with Voyxact approval in US

Immunoglobulin A (IgA) Nephropathy Market Assessment ...

Vera plunges as Otsuka outperforms with IgA nephropathy therapy

Accelerated Approval Atacicept BAFF/APRIL inhibitor Clinical Trials IGA Glomerulonephritis Otsuka Proteinuria Sibeprenlimab TRUTAKNA United States Food and Drug Administration Voyxact

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